On August 27, 2007, FDA published its long-awaited proposed rule to amend the final monograph for Over-the-Counter (“OTC”) sunscreen drug products. The rule, if finalized, would set standards for formulating, testing, and labeling OTC sunscreen drug products with Ultraviolet A (“UVA”) light and Ultraviolet B (“UVB”) light protection. UVA light is responsible for tanning, and UVB light is responsible for sunburn. FDA’s OTC drug sunscreen monograph was finalized in 1999 and discusses the ability of a sunscreen to protect against UVB light, but the effective date of the monograph was later stayed until reliable testing methods for protection against UVA light were developed. (The rulemaking history for OTC sunscreens is available here.) (As an interesting historical note, Congress ordered FDA to issue a final sunscreen monograph within 18 months of enactment of the FDA Modernization Act of 1997 [§ 129]. This led FDA to issue the final monograph on May 21, 1999, effective in two years with UVA testing and labeling deferred. In December 2002, FDA stayed the effective date of the monograph - which stay is still in effect, pending the development of the UVA issues addressed in the Agency’s August 2007 proposal.)
The most significant aspects of FDA’s proposal are the development of a standard testing method to determine a sunscreen’s efficacy to protect against UVA light and the creation of a consumer-friendly rating system for a product's protection against UVA light. According to an FDA press release:
The FDA proposal provides a ratings system for UVA sunscreen products on a scale of one to four stars. One star would represent low UVA protection, two stars would represent medium protection, three stars would represent high protection, and four stars would represent the highest UVA protection available in an OTC sunscreen product. If a sunscreen product does not provide at least a low level (one star) of protection, FDA is proposing to require that the product bear a “no UVA protection” marking on the front label near the SPF value.
Ratings would be derived from two tests the FDA proposes to assess the effectiveness of sunscreens in providing protection against UVA light. The first test measures a product's ability to reduce the amount of UVA radiation that passes through it. The second test measures a product’s ability to prevent tanning. This test is nearly identical to the SPF test used to determine the effectiveness of UVB sunscreen products.
Other proposed amendments to the monograph include:
- Revisions to the UVB labeling regulations, including: (1) the increase of the highest SPF value from SPF30+ to SPF50+; (2) use of the terms “low” and “medium” rather than “minimal” and “moderate” as category descriptors for protection against UVB; and (3) insertion of the term “UVB” before “SPF” and before “sunburn;”
- Renaming the rating for UVB protection (i.e., SPF) from “sun protection factor” to “sunburn protection factor;”
- Addition of avobenzone with zinc oxide and avobenzone with ensulizole as permitted combinations of active ingredients in OTC sunscreens;
- The following mandatory warning in the “Drug Facts” box on the product label: “UV exposure from the sun increases the risk of skin cancer, premature skin aging, and other skin damage. It is important to decrease the UV exposure by limiting the time in the sun, wearing protective clothing, and using a sunscreen;”
- A requirement for a statement to inform consumers about the importance of both UVB and UVA protection;
- Mandatory directions that consumers apply the sunscreen either “liberally” or “generously” and that the sunscreen should be reapplied at least every 2 hours; and
- Various modifications to the SPF testing procedures that are intended to increase protection of persons enrolled in the SPF test and to improve accuracy and reproducibility of the test results.
Although FDA’s proposal does not address nanosize particles, the Agency solicits comments on the safety and effectiveness of nanometer-size sunscreen particles and proposals for regulation of sunscreens containing nanosize particles. Comments concerning this issue will be included in the docket for the proposed monograph, as well as in FDA’s nanotechnology docket. (See 8/1/2007 FDA Law Blog post.)
Timing of the publication of a final rule will largely depend on the number of comments FDA receives. Comments are due by November 26, 2007. With respect to implementation of a final rule, FDA commented that the Agency “understands the seasonal nature of the sunscreen industry and the time required for product testing and relabeling. FDA is also aware that more than 1 year may be needed for implementation. FDA is proposing an 18- to 24-month implementation date and will try to have it coincide with the June/July time period.”